Entecavir 0.5 / 1 mg

Film-Coated Tablets for Oral Use


Product leaflet summary

Therapeutic Indications

Envica tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Envica can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).


Dosage and Administration

Not all patients need to take the same dose of Envica. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For adults the recommended dose is either 0.5 mg or 1 mg once daily orally.

Your dose will depend on:

Whether you have been treated for HBV infection before, and what medicine you received. Whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.

The condition of your liver.



Do not take Envica if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine


Pregnancy and Lactation

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Envica is safe to use during pregnancy.

Envica must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Envica use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Envica. Tell your doctor if you are breast-feeding.

It is not known whether entecavir, the active ingredient in Envica, is excreted in human breast milk.


Ability to Drive and Use Machinery

Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.


Package Presentation:

Envica 0.5 mg supplied in a Pack of 30 tablets.

Envica 1 mg supplied in a Pack of 30 tablets.